Atrial Fibrillation Research In CATalonia

NCT03188484 | Completed DMC

• 2 other identifiers: IDIAP Jordi Gol275/C/2015
• Study Type: observational
• Target: 492
• Locations: 1 country
• Sites: 2

Brief Summary

The AFRICAT study is a prospective, multicenter, population-based study, which aims to create and apply a sequential screening program for atrial fibrillation (AF) in a high-risk population by integrating clinical, electrocardiographic and biological information. The study will be divided into three different phases of generation, validation and application of a screening program. In Phase I, from 8,000 individuals aged 65-75 with hypertension and diabetes identified from primary center registries, 100 will be randomly selected . In these patients, the investigators will complete clinical assessment, testing of different pulse-handheld ECG devices (MyDiagnostik, AliveCor and WatchBP) for AF screening, discovery of blood biomarkers for AF (by aptamer technology and RNA expression), and validation of biological candidates from the literature and previous results. All patients will receive Holter monitoring with a wearable device (NuuboTM). In parallel, a predictive risk model for AF will be developed from historical records from the areas in which the study will be carried out. This Phase I will be followed by a Phase II-validation phase of 400 patients, selected by the predictive model previously mentioned, belonging to the top risk quartile. In these patients, the best biomarkers and devices from phase I will be validated, and patients will be again monitored with the wearable Holter device. With the results from this validation analysis, a screening program (Phase III) based in the combination of clinical predictors, devices to detect AF (handheld-ECG or pulse wave detectors), blood biomarkers determination and long-term monitoring with wearable Holter. This program will be applied over the whole population targeted by the AFRICAT study, which corresponds to 8,000 patients from 65 to 75 years old, whit hypertension and diabetes mellitus as comorbidities.

Conditions

Arrhythmia Atrial; Atrial Fibrillation; Hypertension; Diabetes Mellitus

Keywords

Atrial Fibrillation; Electrocardiography; Biological Markers; Risk Assessment

Outcome Measures

Primary Outcomes (1)

• Atrial fibrillation (AF) diagnosis

  Absence of discrete P waves together with an irregular, arrhythmic pattern of ventricular activation, more than 30 seconds.

  Study visit/1 month monitoring

Eligibility Criteria

• Age: 65 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All people included were managed by the Public Health System. Therefore 5,000 participants aged 65-75 with active diagnoses of hypertension (I10) and diabetes (E10.9 E11.9) will be selected from the electronic health record of Primary Care. Given that the registered prevalence of Atrial Fibrillation in this population is was 7.3%, the investigators estimated that around 2.8% will be newly diagnosed with AF at the first study visit. Therefore, the investigators estimate that the number of patients in this population who have undiagnosed AF might be from 140 to 210 patients, taking into account that AF detection should be improved in the study given the long-term monitoring.

You may qualify if:

• All patients aged 65-75 with active diagnoses of hypertension (I10) and diabetes (E10.9 E11.9)

You may not qualify if:

• Absence or not accessibility to singular person or its clinical record or/and difficulty to follow the instructions about how managing the devices or/and no acceptation of conditions
• Chronic inflammatory diseases
• Active Cancer
• Dementia
• For Phases II-III: previous diagnosis of AF

Sponsors & Collaborators

• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: lead
• Fundación Pública Andaluza para la gestión de la Investigación en Sevilla: collaborator
• Fundació La Marató de TV3: collaborator

Study Sites (2)

SAP Terres de l'Ebre

Tortosa, Tarragona, 43500, Spain

Location

SAP Muntanya

Barcelona, 08035, Spain

Location

Related Publications (5)

• Abellana R, Gonzalez-Loyola F, Verdu-Rotellar JM, Bustamante A, Pala E, Clua-Espuny JL, Montaner J, Pedrote A, Del Val-Garcia JL, Ribas Segui D, Munoz MA. Predictive model for atrial fibrillation in hypertensive diabetic patients. Eur J Clin Invest. 2021 Dec;51(12):e13633. doi: 10.1111/eci.13633. Epub 2021 Jun 19.

  PMID: 34148231 RESULT

• Clua-Espuny JL, Muria-Subirats E, Ballesta-Ors J, Lorman-Carbo B, Clua-Queralt J, Pala E, Lechuga-Duran I, Gentille-Lorente D, Bustamante A, Munoz MA, Montaner J; AFRICAT Research Group. Risk of Atrial Fibrillation, Ischemic Stroke and Cognitive Impairment: Study of a Population Cohort >/=65 Years of Age. Vasc Health Risk Manag. 2020 Oct 28;16:445-454. doi: 10.2147/VHRM.S276477. eCollection 2020.

  PMID: 33149596 RESULT

• Garcia-Berrocoso T, Pala E, Consegal M, Piccardi B, Negro A, Gill N, Penalba A, Huerga Encabo H, Fernandez-Cadenas I, Meisel A, Meisel C, Jickling GC, Munoz MA, Clua-Espuny JL, Pedrote A, Pagola J, Juega J, Bustamante A, Montaner J. Cardioembolic Ischemic Stroke Gene Expression Fingerprint in Blood: a Systematic Review and Verification Analysis. Transl Stroke Res. 2020 Jun;11(3):326-336. doi: 10.1007/s12975-019-00730-x. Epub 2019 Sep 2.

  PMID: 31475302 RESULT

• Muria-Subirats E, Clua-Espuny JL, Ballesta-Ors J, Lorman-Carbo B, Lechuga-Duran I, Fernandez-Saez J, Pla-Farnos R, On Behalf Members Of Africat Group. Incidence and Risk Assessment for Atrial Fibrillation at 5 Years: Hypertensive Diabetic Retrospective Cohort. Int J Environ Res Public Health. 2020 May 16;17(10):3491. doi: 10.3390/ijerph17103491.

  PMID: 32429492 RESULT

• Pala E, Bustamante A, Clua-Espuny JL, Acosta J, Gonzalez-Loyola F, Ballesta-Ors J, Gill N, Caballero A, Pagola J, Pedrote A, Munoz MA, Montaner J. N-Terminal Pro B-Type Natriuretic Peptide's Usefulness for Paroxysmal Atrial Fibrillation Detection Among Populations Carrying Cardiovascular Risk Factors. Front Neurol. 2019 Nov 29;10:1226. doi: 10.3389/fneur.2019.01226. eCollection 2019.

  PMID: 31849809 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

A blood sample of 32 cc divided into two serum tubes (8.5 cc), two plasma EDTA tubes (6 cc) and one TempusTM RNA tube (3 cc). Samples will be processed and stored at -20 ºC at the recruiting center until shipment to Neurovascular Research Laboratory, where the sample bank will be set up.

MeSH Terms

Conditions

Atrial Fibrillation; Hypertension; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Joan Montaner Villalonga, PhD

  Neurovascular Research Group

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Medicine and Surgery

Study Record Dates

• First Submitted: June 13, 2017
• First Posted: June 15, 2017
• Study Start: May 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: October 1, 2019
• Last Updated: April 11, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share

Locations

ES (2)